Transverse connector with cam activated engagers

ABSTRACT

An adjustable transverse connector connects orthopedic stabilization rods that may be parallel or skewed in orientation relative to each other The connector may include two sections that are joined together by a fastener. The connector may be adjustable in many ways. The overall length of the connector may be adjustable. The rod openings of the connector may be partially rotatable about a longitudinal axis of the connector. The two sections of the connector may be angulated. The connector may include cam locks that securely attach the connector to the rods. Rotating a cam lock may extend a rod engager into a rod opening. The rod engager may be a portion of the cam lock. The extension of the rod engager into a rod opening may push a rod against a body of the transverse connector to form a frictional engagement between the connector, the rod, and the rod engager.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention generally relates to bone stabilization systems,and more particularly to a transverse connector for connecting adjacentrods of orthopedic stabilization systems. The transverse connector, orcross-link, may connect together adjacent spinal rods of a spinalstabilization system.

2. Description of Related Art

Bone disorders, degenerative conditions, or trauma may result in a needto stabilize a bone or bones of a patient with an orthopedicstabilization system. For example, disease or trauma may result in theneed to stabilize the spine of a patient. A variety of systems may beused to stabilize a spine. A spinal stabilization system may generallybe classified as an anterior, lateral, or posterior system according toa position of the system relative to the spine. Posterior stabilizationsystems often include pairs of vertically aligned rods for stabilizingboth short and long segments of a spine.

An orthopedic stabilization system may include a pair of rods that arecoupled to a bone or bones. For example, a posterior spinalstabilization system may include a pair of bendable rods that arecontoured and longitudinally disposed adjacent to vertebral bodies of aspine. A pair of rods of an orthopedic stabilization system may becoupled to a bone or bones by fixation elements. The fixation elementsmay include, but are not limited to, hooks and bone screw connectors.

Rods of an orthopedic stabilization system may be oriented so that therods are substantially parallel to each other. Alternately, rods of anorthopedic stabilization system may be oriented so that the rods areskewed relative to each other. In a skewed orientation, the rods may beoriented towards each other so that a horizontal distance between therods is not constant. In other words, the rods may not be horizontallyparallel to each other. FIG. 1 shows a top view of a pair of rods 28that are not horizontally parallel. Also, the rods 28 may be oriented sothat a vertical distance between the rods is not constant. In otherwords, the rods 28 may not be vertically parallel to each other. FIG. 2shows a pair of rods that are not vertically parallel.

Transverse connectors may be attached to connect adjacent rods of anorthopedic stabilization system together. Transverse connectors mayprovide rigidity to a stabilization system. Transverse connectors mayalso inhibit rod movement. Stresses may act to return a stabilized bonesystem to a deformed position. For example, stresses on a spine and on aspinal stabilization system often operate to return a corrected spine toa deformed position. Transverse connectors may inhibit rod movement ofthe spinal stabilization system during a post-operative period so thatthe spine remains in a corrected position.

Many transverse connectors have been developed that link adjacent rodstogether. U.S. Pat. Nos. and patent application Ser. Nos. 09/093,756 toWagner et al.; 5,980,521 to Montague et al.; 5,947,966 to Drewry et al.;5,752,955 to Errico et al.; 5,709,684 to Errico et al.; and 5,667,507 toERRico et al., describe transverse connectors. Each of these patents andpatent applications are incorporated by reference as if fully set forthherein. Many transverse connectors present one or more problems for asurgical team that installs the transverse connectors. Some of theproblems associated with transverse connectors include the need topre-load connectors on a rod, high profiles, wide profiles, separatecomponent fasteners, and proper tightening of threaded fasteners. Also,the ability of a transverse connector to connect rods that are skewedrelative to each other may be problematic.

Some transverse connectors have engaging members that must be preloadedonto a rod prior to the rod being placed within a patient. The use ofpreloaded connectors may require significant pre-operative planning. Theuse of preloaded connectors may inhibit a surgical team's ability tomake changes that are needed to meet conditions presented duringinsertion of the stabilization system in the patient. Other transverseconnectors include rod openings that allow the transverse connector tobe placed on rods after the rods have been attached by fixation elementsto a patient.

Some transverse connectors may have a high profile and/or a wideprofile. These profiles may cause surgical complications to tissue andbone adjacent to the connector. A rod fastening system that attaches thetransverse connector to the adjacent rods may cause a high or wideprofile. For example, a connector that snaps onto a spinal rod may beattached to a transverse connector by a nut that engages a threadedshaft of the connector. The nut and shaft may cause the assembledtransverse connector to have a high profile and a wide profile. A highprofile transverse connector may result in abrasion of tissue adjacentto the transverse connector. A wide profile transverse connector mayrequire the removal of a portion of bone to allow the transverseconnector to be attached to stabilization rods. A slim profile mayrequire less or no bone removal when the transverse connector isattached to stabilization rods.

Some transverse connector rod fastening systems may require separatecomponent fastening members to securely attach the transverse connectorto stabilization rods. A separate component fastener, such as a nut, maybe difficult to properly position and secure during an installationprocedure.

A transverse connector must be securely tightened to a stabilizationrod. Some rod fastening systems of transverse connectors use threadedfasteners to attach the transverse connector to adjacent rods. Thethreaded fastener typically is a setscrew or a nut. Not tightening athreaded fastener enough may allow movement of the transverse connector.Over tightening a threaded fastener may result in damage to thefastening system that could cause failure of the transverse connector.Applying a proper amount of torque to a threaded fastener may requirethe use of a torque wrench. Using a torque wrench may be burdensome to asurgical team that installs a stabilization system. Also, a torquewrench may require frequent calibration to ensure that an indicatedamount of torque is applied when the torque wrench is used.

A threaded fastener such as a setscrew may need to be angled within thebody so that a contact portion engages a rod sufficiently to secure therod to the transverse connector. One type of transverse connector thatutilizes a setscrew operates by contacting the setscrew against a lowerportion of a rod to drive a top portion of the rod against a body of thetransverse connector. The angle of the setscrew may be less than about45° with respect to a longitudinal axis of the transverse connector, Theangle of the setscrew may require an insertion tool with a flexibleshaft to fix the rod to the transverse connector. Alternately, a largeopening may be made in the patient so that an insertion tool without aflexible shaft may be used to fix the rod to the transverse connector.Another type of transverse connector that utilizes a setscrew operatesby contacting the setscrew against an upper portion of a rod to drive alower portion of the rod against a body of the transverse connector.Positioning a pair of rods within such a transverse connector may bedifficult during installation of the transverse connector in a patient.

A transverse connector may include a body, a pair of rod openings in thebody, and rod engagers. The body of the transverse connector may span adistance between a pair of rods. The body may have a fixed length, orthe length of the body may be adjustable. Bending the body may adjustthe length of the body and the orientation of the rod openings relativeto the rods. Alternately, the length of the body may be adjustable byadjusting a position of a first section of the body relative to a secondsection of the body. After the positions of the first section and thesecond section are adjusted, the first section and the second sectionmay be fixed using a fastener. The fastener may be, but is not limitedto, a setscrew or a nut and bolt. The pair of rod openings may hold rodsof a bone stabilization system. The rod engagers may be used to attachrods that are positioned in the rod openings to the body of thetransverse connector.

A pair of rods of a stabilization system may be skewed relative to eachother in both a vertical plane and a horizontal plane. Some transverseconnectors cannot be adjusted to accommodate rods that are horizontallyand/or vertically skewed. Other transverse connectors require a portionof the transverse connector to be bent to accommodate the skew of therods.

A distance between a pair of rods of an orthopedic stabilization systemmay determine positions of rod fastening systems within a transverseconnector. For transverse connectors that are attached to a pair ofclosely spaced rods, the rod fastening systems may be located on outersides of the rod openings. For transverse connectors that are attachedto a pair of rods that are spaced a farther distance apart, one rodfastening system may be located on an outer side of a rod opening andthe other rod fastening system may be located between the two rodopenings. Alternately, both rod fastening systems may be located betweenthe rod openings. Also, for transverse connectors that are attached to apair of rods that are spaced a large distance apart, an adjustablelength transverse connector may be used.

SUMMARY OF THE INVENTION

Transverse connectors may be used to stabilize and inhibit movement ofan orthopedic stabilization system. A transverse connector may be afixed length transverse connector or an adjustable transverse connector.An embodiment of a fixed length transverse connector has a bodyconfigured to resist bending of the transverse connector. An alternateembodiment of a fixed length transverse connector is configured to allowthe body to be bent to allow elongated member openings of the connectorto be oriented relative to elongated members. Bending the fixed lengthtransverse connector may also allow for some length adjustment of thetransverse connector. A bendable fixed length transverse connector mayinclude indentations that facilitate bending the transverse connector.An adjustable transverse connector may allow for adjustment of axialposition, rotation, and/or angulation of a first elongated memberopening relative to a second elongated member opening.

A transverse connector may include a pair of fastening systemsconfigured to couple the transverse connector to elongated members. Afastening system may be a cam system. The cam system may include acontact surface that engages an elongated member or an elongated memberengager when the cam system is activated to couple the transverseconnector to the elongated member. Rotating the cam system may activatethe cam system. A rotation activated cam system preferable does notinclude a threaded connection to the transverse connector so thatrotating the cam system does not axially advance the cam system withinthe transverse connector.

Elongated members of an orthopedic stabilization system may be, but arenot limited to, circular rods or rods having other cross sectionalgeometries. Elongated members may be two separate contoured members thatare positioned on opposite sides of a bone or bones that are to bestabilized. In an alternate embodiment, the elongated members may be twoends of a single bent and contoured elongated member. The elongatedmembers may be coupled to the bone or bones by fixation elements. Thefixation elements may be, but are not limited to, bone screw connectors,hooks, or cable systems. An end portion of a transverse connector may beconfigured to attach to a fastening system of the fixation element thatcouples the fixation element to an elongated member. An opposite endportion of the transverse connector may include an elongated memberopening adapted to couple the transverse connector to an elongatedmember. For example, a threaded shaft extending from a fixation elementmay extend through a slot or hole in an end portion of the transverseconnector. A nut may be coupled and tightened to the shaft to secure thetransverse connector to the fixation element. An opposite end portion ofthe transverse connector may include an elongated rod opening and a camsystem that extends a rod engager against an elongated member positionedwithin the opening. Positioning an elongated member in the elongatedmember opening and activating the cam mechanism secures the transverseconnector to the elongated member positioned within the elongated memberopening.

A transverse connector may include a pair of elongated member openings.The elongated member openings may include open sections that allow theelongated member openings to be top loaded onto elongated members. Theelongated members may be attached by fixation elements to a patientbefore the transverse connector is coupled to the elongated members. Inan alternate embodiment, an elongated member opening may not include anopen section that allows the elongated member opening to be top loadedonto an elongated member. To use a transverse connector that does notinclude an open section in an elongated member opening, the elongatedmember opening is placed over an end of the elongated member andmaneuvered to a desired location before the elongated member is attachedwithin the patient by fixation elements.

A fastening system of a transverse connector may be a cam system. Thecam system may extend an engager into an elongated member opening of thetransverse connector. The engager may secure the transverse connector toan elongated member positioned in the elongated member opening. An upperportion of the cam system may reside substantially within a body of thetransverse connector to maintain a low profile of the transverseconnector. A cam system may be unthreaded so that the cam system doesnot axially advance into or out of the transverse connector during use.In an embodiment, the cam system includes a cam that contacts theelongated member when the cam system is engaged. In alternateembodiments, a cam system may contact a separate component engager thatextends into an elongated member opening to secure an elongated memberto the transverse connector.

A cam system may be angled within a body of a transverse connector sothat the transverse connector has a low profile. Placing the cam systemat an angle within the body may allow for a strong connection between anelongated member and the transverse connector. The angle of the camsystem within the body may allow for easy insertion of a drive toolwithin the cam system without the need to have a wide surgical openingin a patient. The cam system may be angled within the body at an anglein a range from about 45° to 90° with respect to a longitudinal axis ofthe transverse connector, and may preferably be angled about 70° withrespect to the longitudinal axis of the transverse connector.

Portions of a cam system and portions of a body of a transverseconnector may lock the cam system within the body to inhibit removal ofthe cam system from the body. Having the cam systems locked within thebody makes the cam systems of the transverse connector unitary membersof the transverse connector. The transverse connector may be provided toa surgeon as a single unit that includes no separate pieces that need tobe attached to the transverse connector during installation of thetransverse connector within a patient. Also, the transverse connectorhas no pieces that may fall out of the connector during an installationof the transverse connector within the patient.

A cam system may include a tool opening that is adapted to accept adriving tool. The driving tool may be, but is not limited to, a diamonddrive, a hex wrench, a star drive, a screwdriver, or a socket wrench.The driving tool may allow the transverse connector to be top tightened.Rotating the driving tool, and thus the cam system, may move the camsystem from an initial position to an engaged position. In the engagedposition, the cam system will securely couple an elongated memberpositioned within an elongated member opening to the transverseconnector. The cam system may engage the elongated member when the camsystem is rotated a specific number of degrees. The number of degreesmay be a value within the range from about 10° to about 360°. In anembodiment, rotating the driving tool approximately 170° couples theelongated member to the transverse connector. The cam system may includea stop that inhibits movement of the cam system beyond the engagedposition.

A tool opening in a cam system may be keyed to accept a driving toolonly in a specific orientation. The specific orientation may provide auser with a visual indication that the cam system is fully engaged whenthe drive tool is used to rotate the cam system. For example, the toolopening may be adapted to accept a diamond drive that can only beinserted into the tool opening in certain preferred orientations. Whenthe diamond drive is inserted into the tool opening, a handle of thedrive tool may be oriented at an angle relative to an elongated memberpositioned in an elongated member opening adjacent to the cam system.The drive tool may be rotated to rotate the cam system to an engagedposition. The handle of the drive tool may be oriented substantiallyparallel to the elongated member when the cam system is in the engagedposition. The orientation of the drive tool handle before and afterrotation may be a visual indication to a user that the cam system hasbeen activated to secure the elongated member to the transverseconnector. A diamond drive may also provide a large contact area betweena head of the drive tool and side walls of the tool opening. The largecontact area may inhibit stripping or deformation of the tool openingduring use. In alternate embodiments, the tool opening may be slotted,and the drive tool may include protrusions that fit within the slotsonly when a handle of the drive tool is in a specific orientation.

An engager of the cam system may be a cam that extends into an elongatedmember opening when the cam system is rotated. When the cam system is inan initial orientation, the engager may be positioned so that theengager does not extend into the elongated member opening of thetransverse connector. In an alternate embodiment, a cam surface of thecam system may contact a separate component engager that extends intothe elongated member opening when the cam system is engaged.

A surface of an elongated member opening, a contact surface of anengager, and/or an elongated member may be textured to inhibit movementof the transverse connector relative to the elongated member when a camsystem couples the transverse connector to the elongated member. Theengager may dimple the elongated member when the cam system is engagedto couple the elongated member to the transverse connector.

A fixed length transverse connector may include a body, a pair ofelongated member openings and a pair of cam systems configured to coupleelongated members to the transverse connector. The body of thetransverse connector may include indentations that allow the transverseconnector to be bent. Bending the transverse connector may allow forminor adjustment of a separation distance between elongated memberopenings of the transverse connector. Bending the transverse connectormay also allow the elongated member openings to be properly orientedrelative to elongated members of an orthopedic stabilization system sothat there is a large contact area between an elongated member and anelongated member opening.

For fixed length transverse connectors that have small separationdistances between the elongated member openings, one or both cam systemsof the transverse connectors may be positioned so that the cam systemsare not located between the elongated member openings. A cam system thatis not located between the elongated member openings of a transverseconnector is referred to as an outward positioned cam system. Inembodiments, fixed length transverse connectors having separationdistances between centers of the elongated member openings less thanabout 23 millimeters (mm) may have at least one outward positioned camsystem.

For fixed length transverse connectors that have larger separationdistances between the elongated member openings, the cam systems may belocated between the elongated member openings of the transverseconnector. In embodiments, fixed length transverse connectors havingseparation distances between centers of the elongated member openingsgreater than about 23 mm may have cam systems positioned betweenelongated member openings of the transverse connector. Transverseconnectors may be provided in incremental lengths up to lengths betweencenters of elongated member openings of about 40 mm. Longer transverseconnectors may also be formed.

An adjustable transverse connector may securely connect a pair ofadjacent elongated member in a bone stabilization system. A pair ofadjacent elongated member may be attached by fixation elements to a boneor bones within a patient. The elongated member may be skewed relativeto each other. The transverse connector may be adjustable to accommodatevariations in placement of adjacent elongated members. The transverseconnector may be adjusted by adjusting a position of a first section ofthe transverse connector relative to a second section of the transverseconnector. In an embodiment, the first section and the second section ofan adjustable transverse connector may be adjusted relative to eachother about at least two axes. In an alternate embodiment, the firstsection and the second section of an adjustable transverse connector maybe adjusted relative to each other about at least three axes. After thepositions of the first section and the second section are adjusted, afastener may fix the position of the first section relative to thesecond section.

In an embodiment, an adjustable transverse connector may allow foradjustment of a distance between elongated member openings and forrotation of a first elongated member opening relative to a secondelongated member opening. A first section of the transverse connectormay include a shaft that telescopically fits within a hollow shaft of asecond section of the transverse connector. Sliding the shaft of thefirst section within the hollow shaft of the second shaft allows foradjustment of the separation distance between elongated member openingsof the transverse connector. An end of the first section shaft may beflared to inhibit removal of the shaft from the hollow section. Thefirst shaft may be turned within the hollow shaft to allow the firstelongated member to be rotated relative to the second elongated member.The hollow shaft may include a collet. A collar may be compressionlocked to the collet to inhibit movement of the first section relativeto the second section. The collar may include a tab that fits within aslot of the collet. The tab and slot combination locates the collarrelative to the collet so that a compression locking instrument may beeasily positioned and used to lock the collar to the collet withoutundue manipulation of the collar.

An embodiment of a transverse connector may allow a length, a rotationangle, and an angulation angle between a first section of the transverseconnector and a second section of the transverse connector to beadjusted. When the transverse connector is properly adjusted, tighteninga fastener inhibits motion of the first section relative to the secondsection. The fastener of a transverse connector may be a component of afastening system. The fastening system may include a lining. The liningmay be, but is not limited to a bushing or a sleeve. The lining may bepositioned within the second section of the transverse connector. Thefirst section of the transverse connector may be positioned through thelining and the second section.

To adjust a length of a transverse connector, a distance between anelongated member opening in the first section and an elongated memberopening in the second section may be adjusted by moving the elongatedmember opening of the first section towards or away from the elongatedmember opening of the second section. A transverse connector may allowadjustment of the length of the transverse connector within a limitedrange. For example, an embodiment of a transverse connector may have anadjustment range between centers of elongated member openings of fromabout 37 mm to 44 mm, another embodiment may have an adjustment range offrom about 43 mm to 51 mm, another embodiment may have an adjustmentrange of from about 50 mm to 65 mm, and another embodiment may have anadjustment range of from about 61 to 80 mm. Other adjustment ranges mayalso be used.

An opening through the second section may be sized to allow the firstsection to be angled relative to the second section. A width of theopening may allow only a limited range of angulation between the firstsection and the second section. For example, the width of the openingmay allow the angulation of the first section relative to the secondsection from about 0° to about 18°. An opening may be positioned throughthe second section so that smaller or larger angulation ranges arepossible. For example, the width of the opening may allow the angulationof the first section relative to the second section in a range of from0° to 10°, or in a range from 0° to 30°. The opening may be offset froma longitudinal axis of the second section so that the angulation of thefirst section relative to the second section does not have a lower limitof 0°. For example, the opening of the second section may allow anangulation range of from 10° to 35°. In other embodiments, differentangulation ranges and limits for the angulation ranges are possible. Ifa transverse connector cannot be angulated in the direction of a desiredorientation, a section that is placed over an elongated member may beremoved from the elongated member and placed on the opposite elongatedmember to allow the transverse connector to be angulated in the desireddirection.

An opening may also allow the first section to rotate relative to thesecond section. The first section may include a shaft that has a flatportion. A height of the opening in the second section may be sized sothat an edge of the flat portion of the shaft engages the second sectionwhen a user attempts to rotate the first section beyond a limitedrotation range. The engagement between the shaft and the second sectionmay limit the range of rotational motion of the first section relativeto the second section. In an embodiment, the first section is configuredto rotate plus or minus 10° relative to the second section. In otherembodiments, the rotational range of motion may be greater or less thanplus or minus 10°. For example, the rotation of the first sectionrelative to the second section may be limited to plus or minus 5°, orthe rotation of the first section relative to the second section may belimited to plus or minus 20°. Other embodiments may have differentrotational limits.

When the position of the first section relative to the second positionis properly adjusted, the position may be set by tightening a fastenerof the fastener system. In an embodiment, the fastener is a setscrewthat pushes against a lining. Tightening the fastener creates shearforces between the setscrew, the lining, the first section, and thesecond section. The shear forces inhibit motion of the first sectionrelative to the second section. The fastener may be another type offastener, including, but not limited to, a nut or a cam member.

An adjustable transverse connector may include a fastening system thatsecurely attaches the transverse connector to an elongated member of anorthopedic stabilization system. In an embodiment, the fastening systemis a cam system. In alternate embodiments the fastening system may be,but is not limited to, a setscrew, a clamping system, or a nut andthreaded fastener.

A first section and a second section of the transverse connector may beconfigured to be inseparable after assembly. A fastener used to fix theposition of the first section of the body and the second section of thebody may be threaded into the transverse connector. In an embodiment,the fastener may be inhibited from being removed from the transverseconnector. The transverse connector may be supplied as an assembled unitto a surgeon who will install the transverse connector in a patient.Having fastening systems pre-installed in the transverse connector, thefirst section inseparable from the second section, and the fastenerthreaded on the transverse connector makes the transverse connector aunitary structure. The unitary structure transverse connector may beeasy to install within a patient because the transverse connectorincludes no separate pieces that need to be attached during installationwithin a patient. Also, the unitary structure has no pieces that mayfall out of the connector, be misplaced be cross threaded, or beincorrectly positioned during an installation procedure within thepatient.

A drive tool used to tighten a fastener that secures a first section ofa transverse connector to a second section of the transverse connectormay be the same instrument that is used to tighten fastening systemsthat couple elongated members to the transverse connectors. Using thesame instrument to tighten the fastener and engage the cam system mayminimize the instrument set needed to install a transverse connectorwithin a patient. If the fastener that secures the first section of thetransverse connector to the second section of the transverse connectoris a threaded connector, a torque wrench may be attached to the drivetool so that a proper amount of torque may be applied to the fastener.

When a fastener that inhibits motion of a first section of a transverseconnector relative to a second section of the transverse connector or afastening system that couples an elongated member to the transverseconnector is tightened, a counter-torque wrench may be coupled to thetransverse connector. The counter-torque wrench allows the applicationof an offset torque to the transverse connector. The offset torque mayprevent undesired movement of a stabilization system or patient when thefastener or a fastening system is rotated.

An advantage of a fixed length transverse connector is that thetransverse connector may be a unitary structure that has no removableparts. The transverse connector may be top loaded onto elongatedmembers. The absence of removable parts, such as setscrews or fasteners,may allow the transverse connector to be easily and quickly installedwithin a patient. The unitary structure also has no parts that can fallout of the transverse connector, be misplaced, be cross threaded, or beincorrectly positioned during installation.

An advantage of an adjustable transverse connector is that thetransverse connector may be supplied to a surgeon as a single unit. Thetransverse connector may be top loaded onto elongated members. The unithas no separable parts, and if the unit includes threaded members, thethreaded members may be pre-attached to the unit. Pre-attaching threadedmembers to the unit avoids the need to thread the parts into the unitduring installation within the patient.

An advantage of a transverse connector that uses cam systems to couplethe transverse connector to elongated members is that the transverseconnector may be attached to the elongated members without the use ofthreaded fasteners. The absence of threaded fasteners allows theconnector to be attached to an elongated member without the transverseconnector being under-tightened or over-tightened. The cam system mayinclude an indicator that informs the user when the transverse connectoris properly fastened to an elongated member. The indicator may be avisual indication, such as a position of a driving tool, and/or theindicator may be a vibrational signal transmitted to the user when thecam system is activated.

An advantage of transverse connectors is that several sizes of fixedlength connectors and several adjustable transverse connectors may beprovided to a surgeon who will install a stabilization system within apatient. The different types and sizes of transverse connectors mayallow a surgeon to install a stabilization system that best fits apatient.

An advantage of an adjustable transverse connector is that the connectormay be used to connect orthopedic rods that are not oriented parallel toeach other. The transverse rod may be used to connect rods that are nothorizontally parallel and/or vertically parallel. The transverseconnector may also be used to connect rods that are oriented parallel toeach other.

Another advantage of a transverse connector is that the transverseconnector may have a thin and low profile. The low profile of thetransverse connector may allow the transverse connector to have aminimal effect on adjacent tissue when the transverse connector isinstalled within a patient. The thin profile may allow the transverseconnector to be easily positioned at desired locations on astabilization system. Further advantages of transverse connectors mayinclude that the transverse connectors are sturdy, durable, lightweight, simple, efficient, reliable and inexpensive; yet the transverseconnectors may also be easy to manufacture, install, and use.

Further modifications and alternative embodiments of various aspects ofthe invention will be apparent to those skilled in the art in view ofthis description. Accordingly, this description is to be construed asillustrative only and is for the purpose of teaching those skilled inthe art the general manner of carrying out the invention. It is to beunderstood that the forms of the invention shown and described hereinare to be taken as the presently preferred embodiments. Elements andmaterials may be substituted for those illustrated and described herein,parts and processes may be reversed, and certain features of theinvention may be utilized independently, all as would be apparent to oneskilled in the art after having the benefit of this description of theinvention. Changes may be made in the elements described herein withoutdeparting from the spirit and scope of the invention as described in thefollowing claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Further advantages of the present invention will become apparent tothose skilled in the art with the benefit of the following detaileddescription of the preferred embodiments and upon reference to theaccompanying drawings in which:

FIG. 1 is a top elevational view of a pair of horizontally skewed rods;

FIG. 2 is a front elevational view of a pair of vertically skewed rods;

FIG. 3 is a top elevational view of a portion of a spinal stabilizationsystem;

FIG. 4 is a perspective view of a transverse connector with cam systemsthat are not positioned between elongated member openings in thetransverse connector;

FIG. 5 is a perspective view of a transverse connector with cam systemsthat are positioned between elongated member openings in the transverseconnector;

FIG. 6 is a perspective view of an adjustable transverse connector thatmay be adjusted about three degrees of freedom;

FIG. 7 is a perspective view of an adjustable transverse connector thatmay be adjusted about two degrees of freedom;

FIG. 8 shows a perspective view of a pair of transverse connectorbenders;

FIG. 9 shows a detailed view of the heads of a pair of benders with atransverse connector positioned within the benders;

FIG. 10 is a cross sectional view of a transverse connector takensubstantially along plane 10-10 of FIG. 5, without cam systems withinthe transverse connector;

FIG. 11 is a bottom elevational view of a fixed length transverseconnector;

FIG. 12 is an elevational view of a textured surface portion of anelongated member opening surface of a transverse connector;

FIG. 13 is a perspective view of a cam system;

FIG. 14 is a perspective view of a drive tool that may be used to rotatea fastener and/or cam system of a transverse connector;

FIG. 15 is a perspective detail of drive head of the drive tool of FIG.14;

FIG. 16 is a perspective view of a torque limiting wrench;

FIG. 17 is an exploded view of an adjustable transverse connector;

FIG. 18 is a perspective view of a torque wrench;

FIG. 19 is a top elevational view of an angulated adjustable transverseconnector;

FIG. 20 is a cross sectional view of a transverse connector takensubstantially along plane 20-20 of FIG. 19, with only one cam systemwithin the transverse connector;

FIG. 21 is a top elevational view of a rotated adjustable transverseconnector;

FIG. 22 is a cross sectional view of an adjustable transverse connectortaken substantially along line 22-22 of FIG. 21;

FIG. 23 shows a perspective view of an embodiment of a head of a benderthat has two pockets;

FIG. 24 shows a perspective view of the embodiment of the head of thebender shown in FIG. 23 engaged to an adjustable transverse connector;

FIG. 25 shows a cross sectional view of a portion of the adjustabletransverse connector shown in FIG. 7; and

FIG. 26 is a perspective view of an instrument used to inhibit movementof a first section of a transverse connector relative to a secondsection of the transverse connector when the transverse connector has acollet and collar fastening system.

While the invention is susceptible to various modifications andalternative forms, specific embodiments thereof are shown by way ofexample in the drawings and will herein be described in detail. Thedrawings may not be to scale. It should be understood, however, that thedrawings and detailed description thereto are not intended to limit theinvention to the particular form disclosed, but on the contrary, theintention is to cover all modifications, equivalents and alternativesfalling within the spirit and scope of the present invention as definedby the appended claims.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

With reference to the drawings, transverse connectors are denotedgenerally as 30. Transverse connectors 30 may be used to connectelongated members 28 of an orthopedic stabilization system 32 together.Transverse connectors 30 may provide rigidity to the orthopedicstabilization system 32. Transverse connectors 30 may also inhibitundesired motion of the orthopedic stabilization system 32. Transverseconnectors 30 may be fixed length transverse connectors or adjustablelength transverse connectors. The elongated members 28 of an orthopedicstabilization system 32 may be coupled to bones 34 by fixation elements36. The fixation elements 36 may be, but are not limited to, hooks andbone screw connectors. In an embodiment, the elongated members 28 arespinal rods that are coupled to vertebral bodies 34 by fixation elements36. The spinal rods 28, fixation elements 36, and transverse connectors30 form part of a spinal stabilization system 32. FIG. 3 shows a portionof an embodiment of a spinal stabilization system 32.

Elongated members 28 of an orthopedic stabilization system 32 may be,but are not limited to, circular rods or rods having other crosssectional geometries. Other types of cross sectional geometries forelongated members 28 may include, but are not limited to, oval,rectangular, or polygonal shaped cross sectional areas. Elongatedmembers 28 may be two separate contoured members that are positioned onopposite sides of a bone or bones 34 that are to be stabilized. In analternate embodiment, the elongated members 28 may be two ends of asingle bent and contoured elongated member. The elongated members 28shown in FIG. 3 are two ends of a single bent and contoured elongatedmember.

A transverse connector 30 may include body 38, a pair of elongatedmember openings 40, and fastening systems 42 that couple the transverseconnector to elongated members 28. The fastening systems 42 may be camsystems. The body 38 of the transverse connector 30 spans a distancebetween a pair of elongated members 28 of an orthopedic stabilizationsystem 32 during use. A body 38 of a fixed length transverse connector30′ may be a single member that optionally includes at least oneindented surface 44. FIGS. 4 and 5 show embodiments of fixed lengthtransverse connectors 30′. A body 38 of an adjustable transverseconnector 30″ may include first section 46 and second section 48. Theposition of the first section 46 may be adjustable relative to theposition of the second section 48. FIGS. 6 and 7 show embodiments ofadjustable length transverse connectors 30″. The components of atransverse connector 30 may be made of biocompatible material including,but not limited to titanium, titanium alloys, stainless steel andceramics.

A transverse connector 30 may include a pair of elongated memberopenings 40. Surfaces 50 of the elongated member openings 40 may closelyconform to a shape of an exterior surface of an elongated member 28 sothat a tight fit is formed between the surface and the elongated memberwhen the transverse connector 30 is coupled to the elongated member. Theelongated member openings 40 may include open sections that allow theelongated member openings to be top loaded onto elongated members 28.The elongated members 28 may be attached by fixation elements 36 to apatient before the transverse connector 30 is coupled to the elongatedmembers. In an alternate embodiment, an elongated member opening 40 maynot include an open section that allows the elongated member opening tobe top loaded onto an elongated member 28. To use a transverse connector30 that does not include an open section in an elongated member opening40, the elongated member opening is placed over an end of the elongatedmember 28 and maneuvered to a desired location before the elongatedmember is attached within the patient by fixation elements 36.

A fixed length transverse connector 30′ may include a body 38, a pair ofelongated member openings 40, and a pair of cam systems 42 configured tocouple the transverse connector to elongated members 28. The body 38 ofthe transverse connector 30′ may include indentations 44 that allow thetransverse connector to be bent. Bending the transverse connector 30′may allow for minor adjustment of a separation distance betweenelongated member openings 40 of the transverse connector. Bending thetransverse connector 30′ may also allow the elongated member openings 40to be properly oriented relative to elongated members 28 of anorthopedic stabilization system 32 so that there is a large contact areabetween an elongated member and an elongated member opening. FIG. 8shows an embodiment of a pair of benders 52, 54 that may be used toadjust a transverse connector 30′. FIG. 9 shows a detail view of atransverse connector 30′ positioned within heads 56 of the benders 52,54. When a transverse connector 30′ is placed within heads 56 of thebenders 52, 54, handles 58 of the benders may be grasped and forcedtowards each other to bend the transverse connector.

For fixed length transverse connectors 30′ that have small separationdistances between the elongated member openings 40, one or both camsystems 42 of the transverse connectors may be positioned so that thecam systems are not located between the elongated member openings. A camsystem 42 that is not located between the elongated member openings 40of a transverse connector 30′ is referred to as an outward positionedcam system. In embodiments, fixed length transverse connectors 30′having separation distances between centers of the elongated memberopenings 40 less than about 80 mm may have at least one outwardpositioned cam system. Embodiments of transverse connectors 30′ withoutward positioned cam systems 42 may be produced in incrementallyincreasing sizes. For example, three sizes of transverse connectors 30′with outward positioned cam systems 42 may be produced in 5 mmincrements with the smallest transverse connector having a separationdistance between centers of elongated member openings 40 of about 10 mm.FIG. 4 shows an embodiment of a transverse connector 30′ having outwardpositioned cam systems 42. Transverse connectors 30′ having outwardpositioned cam systems 42 may also be produced in other size ranges andin different incremental lengths.

For fixed length transverse connectors 30′ that have larger separationdistances between the elongated member openings 40, the cam systems 42may be located between the elongated member openings of the transverseconnector. Fixed length transverse connectors 30′ having separationdistances between centers of the elongated member openings 40 greaterthan about 15 mm may have cam systems 42 positioned between elongatedmember openings of the transverse connector. Embodiments of transverseconnectors 30′ with cam systems 42 positioned between elongated memberopenings 40 may be produced in incrementally increasing sizes. Forexample, four sizes of transverse connectors 30′ with cam systems 42positioned between elongated member openings 40 may be produced in 5 mmincrements with the smallest transverse connector having a separationdistance between centers of elongated member openings of about 25 mm.FIG. 5 shows an embodiment of a transverse connector 30′ having camsystems 42 positioned between elongated member openings 40. Transverseconnectors 30 having cam systems 42 positioned between elongated memberopenings 40 may also be produced in other size ranges and in differentincremental lengths.

FIG. 10 shows a cross sectional view of a fixed length transverseconnector 30′ without cam systems 42 positioned within cam systemopenings 60. Cam system openings 60 of a transverse connector 30 mayinclude shoulders 62 and cam guides 64. The shoulders 62 providesurfaces that may inhibit removal of cam systems 42 that are positionedwithin the cam system openings 60. When a cam system 42 is inserted intoa cam system opening 60, the cam system may be substantially containedwithin the body 38 so that the cam system does not extend a substantialdistance above upper surface 66 of the body.

Cam guides 64 may provide limits for rotational motion of cam systems 42within cam system openings 60 of a transverse connector body 38. The camguides 64 may also limit an insertion depth of the cam system 42 intothe body 38. FIG. 11 shows a bottom view of an embodiment of atransverse connector 30′ with cam guides 64.

A portion of a cam system opening 60 may be formed in an inner surface50 that defines an elongated member opening 40 of the transverseconnector 30. The portion of the cam system opening 60 formed in theinner surface 50 of the elongated member opening 40 allows engager 68 toextend into the elongated member opening 40 and contact an elongatedmember 28 positioned within the elongated member opening during use. Inan embodiment, the engager 68 is cam surface 70 of the cam system 42.

Cam system openings 60 may be angled within the body 38 relative to alongitudinal axis 72 of the transverse connector 30. Alternately, thecam system openings 60 may be formed perpendicular to the longitudinalaxis 72 of the transverse connector 30. An angled cam system opening 60allows an engager 68 to contact an elongated member 28 below the midpoint of the elongated member so that the engager may press an upperportion of the elongated member against surface 50 of the elongatedmember opening 40. A longitudinal axis 73 of a cam system opening 60(and a longitudinal axis of a cam system 42 positioned within theopening) may be angled at an angle A with respect to the longitudinalaxis 72 of the transverse connector 30, as shown in FIG. 10. A camsystem opening 60, and a cam system 42 positioned within the opening,may be angled from about 45° to 90° relative to the longitudinal axis 72of the transverse connector 30. Preferably, the cam system openings 60are angled greater than 60° relative to the longitudinal axis 72 of thetransverse connector 30. For example, in an embodiment, the cam systemopenings 60 are angled at 70° relative to the longitudinal axis 72 ofthe transverse connector 30. The large angle of the cam system opening60 may allow for easy access to tool opening 74 of a cam system 42positioned within the cam system opening. An opening in a body of othertransverse connectors, such as a transverse connector shown in U.S. Pat.No. 5,947,966, may be formed at a significantly smaller angle relativeto the longitudinal axis of the transverse connector, such as about 45°.The smaller angle of an opening in other transverse connectors may makeaccessing a tool opening more difficult and/or inconvenient during aninstallation procedure.

An initial manufacturing process that forms an elongated member 28 mayform an outer surface of the elongated member as a smooth surface. Asubsequent process may texture the outer surface of the elongated member28. Similarly, an initial manufacturing process that forms a transverseconnector 30 may form elongated member opening surfaces 50 as smoothsurfaces. A subsequent process may texture the elongated member openingsurfaces 50. Also, elongated member contact surfaces of engagers 68 maybe textured. Texturing an outer surface of an elongated member 28,elongated member opening surfaces 50, and/or contact surfaces ofengagers 68 may provide large coefficients of friction between theelongated member and the transverse connector 30 as compared to similarsmooth surfaces so that motion of the elongated member is inhibited whenthe transverse connector is coupled to the elongated member. The outersurface of an elongated member 28, elongated member opening surfaces 50,or contact surfaces of engagers 68 may be textured by any texturingprocess, including but not limited to, scoring the surface, a ballpeening process, an electric discharge process, or embedding hardparticles within the surface. FIG. 12 shows an embodiment of a portionof a textured elongated member opening surface 50 of an elongated memberopening that has a scored surface

FIG. 13 shows an embodiment of a cam system 42 that is positionablewithin a cam system opening 60 of a transverse connector 30. The camsystem 42 may include protrusions 76, main body 78, and cam surface 70.When a cam system 42 is inserted into a cam system opening 60, wall 80of the cam system opening (shown in FIG. 10) may compress all of theprotrusions 76 inwards. The protrusions 76 may snap back to theiroriginal configuration when upper surfaces 82 of the protrusions 76 passthe shoulder 62 of the cam system opening 60. If a force is applied tothe cam system 42 that tends to force the cam system out of the camsystem opening 60, the upper surfaces 82 may engage the shoulder 62 toinhibit removal of the cam system from the cam system opening.

FIG. 7 shows an embodiment of a transverse connector 30 that includes avibrational-indicator that informs a user that a cam system 42 has beenengaged. The transverse connector 30 includes pin 84 positioned throughthe transverse connector body 38 so that a portion of the pin extendsinto a cam system opening 60 adjacent to protrusions 76 of the camsystem 42. If the cam system 42 is rotated, a protrusion 76 will contactthe pin 84 so that the protrusion is deflected inwards. When the edge ofthe deflected protrusion 76 passes the pin 84, the protrusion snaps backoutwards and transmits a vibration through the transverse connector body38. The vibration may be heard and/or felt by a user. The vibration mayinform a user that the cam system 42 is being engaged. A certain numberof vibrations may indicate to a user that the cam system 42 is fullyengaged. For example, if there are six protrusions 76, and if the camsystem 42 is fully engaged when the cam system is rotated 180°, threeseparate vibrations during rotation of the cam system would indicatethat the cam system is fully engaged.

A main body 78 of a cam system 42 may fit within a cylindrical portionof a cam system opening 60. An insertion depth of the cam system 42 intoa transverse connector body 38 may be limited when the main body 78contacts a cam guide 64 of the transverse connector body. When a camsystem 42 is placed within a cam system opening 60 so that the main body78 contacts a cam guide 64, the upper surfaces 82 of the protrusions 76may pass past the shoulder 62 of the cam system opening so that removalof the cam system from the cam system opening is inhibited.

Tool opening 74 may be formed in the main body 78. The tool opening 74may allow insertion of drive tool 86 in the main body 78 so that the camsystem 42 may be rotated. The tool opening 74 may be configured toaccept drive head 88 of the drive tool 86. The drive tool 86 may be, butis not limited to, a diamond drive, a hex wrench, a star drive, ascrewdriver, or a socket wrench. FIG. 14 shows an embodiment of a drivetool 86 that may be used to tighten a cam system 42 of a transverseconnector 30. The drive tool 86 may include handle 90, shaft 92, anddrive head 88. The handle 90 may be shaped so that a user maycomfortably and securely grasp and use the drive tool 86. The handle 90may have an elongated shape that can be aligned relative to thetransverse connector 30 or an elongated member 28 to provide anindication during use that the transverse connector has been coupled tothe elongated member. In an embodiment of a drive tool 86, the drivetool has a “T”-shaped handle 90, as shown in FIG. 14. The shaft 92 ofthe drive tool 86 may mechanically attach the handle 90 to the drivehead 88. FIG. 15 shows a detail view of an embodiment of the drive head88 of a diamond drive tool 86.

FIG. 16 shows an embodiment of torque limiting wrench 94 that may beused when a cam system 42 of a transverse connector 30 is tightened. Thetorque limiting wrench 94 may inhibit undesired motion of a patient orparts of a stabilization system 32 when a cam system 42 is rotated. Thetorque limiting wrench 94 may include hollow shaft 96, head 98, andhandle 100. A drive tool shaft 92 may be placed through the hollow shaft96 and into a tool opening 74. The head 98 may be placed on thetransverse connector 30 so that inner surfaces of the lips 102 of thehead contact sides of the transverse connector. The drive tool 86 may berotated one direction to apply a torque to a cam system 42. Force may beapplied to the handle 100 in the opposite direction to counter thetorque applied to the cam system 42.

A tool opening 74 of a cam system 42 may be configured to accept a drivetool 86 in an initial desired orientation. The diamond drive tool head88 shown in FIG. 15 may be inserted into a tool opening 74 of a camsystem 42 in only two orientations. In either orientation, handle 90 maybe offset at an angle from an elongated member 28 positioned within anelongated member opening 40 of the transverse connector 30. Rotating thedrive tool 86 rotates the cam system 42 so that an elongated member 28positioned within an elongated member opening 40 adjacent to the camsystem is secured to the transverse connector 30. A user may be able tofeel resistance to turning that indicates that the transverse connector30 is being securely coupled to the elongated member 28. A cam guide 64of the transverse connector 30 may limit the rotation range of the camsystem 42. The position of the handle 90 after rotation may provide avisual indication to a user that the transverse connector 30 has beensecurely coupled to the elongated member 28. In an embodiment, thehandle 90 of the drive tool 86 is oriented substantially parallel to theelongated member 28 after the drive tool has been rotated to fullyengage the transverse connector 30 to the elongated member. In otherembodiments, the handle 90 may be substantially perpendicular to theelongated member 28 when the transverse connector 30 is fully engaged tothe elongated member. Other types of visual indication systems may beused to determine when an elongated member 28 is secured to a transverseconnector 30. For example, markings on the shaft 92 may align withmarkings on the transverse connector 30 to indicate that an elongatedmember 28 has been coupled to the transverse connector.

In an embodiment, a cam system 42 may fully engage a transverseconnector 30 to an elongated member 28 when the cam system is rotated170°. A handle 90 of a drive tool 86 may be initially offset from theelongated member 28 by about 10° when the drive tool bead 88 ispositioned in a tool opening 74 of the cam system 42. When the drivetool 86 is rotated 170° to secure the elongated member 28 to thetransverse connector 30, the handle 90 may become substantially parallelto the elongated member. Embodiments of cam systems 42 may fully engagetransverse connectors 30 to elongated member 28 when the cam systems arerotated less or greater than 170°. For example, in an embodiment, a camsystem 42 is configured to fully engage a transverse connector 30 to anelongated member 28 when the cam system is rotated about 10°. In anotherembodiment, a cam system lock 42 is configured to fully engage atransverse connector 30 to an elongated member 28 when the cam system isrotated about 360°. Other embodiments of cam systems 42 may beconfigured to fully engage a transverse connector 30 to an elongatedmember 28 when the cam system is rotated to some desired value between10° and 360°.

FIG. 11 shows a bottom view of an embodiment of a transverse connector30. One engager 68 is shown fully engaged against an elongated member28. Another engager 68 is shown in an initial or unengaged position. Thecams 68 of the transverse connector 30 shown in the embodiment of FIG.11 become fully engaged against an elongated member 28 when the camssystems 42 are rotated 170°.

To form a fixed length transverse connector 30′, the body 38 of thetransverse connector is machined to form elongated member openings 40,cam system openings 60 for cam systems 42, and cam guides 64. Indentions44 may be formed in the body 38 to allow the transverse connector 30′ tobe bent. Cam systems 42 are also machined. The elongated member openingsurfaces 50 and/or the contact surfaces of the engagers 68 may betextured so that the coefficient of friction between the surfaces andelongated members 28 placed against the surfaces will be high. The camsystems 42 may be inserted into the cam system openings 60 until theupper surfaces of the protrusions 76 pass the shoulders 62 of the camsystem openings. When the cam systems 42 are inserted into the camsystem openings 60, the transverse connector 30′ is formed.

To establish a bone stabilization system 32, a pair of elongated members28 may be coupled to the bone or bones 34 being stabilized. Theelongated members 28 may be coupled to the bone or bones 34 by fixationelements 36 (shown in FIG. 3). A transverse connector 30′ may be placedover the elongated members 28 so that the elongated members arepositioned within elongated member openings 40 of the transverseconnector 30 at a desired location. If necessary or desired, thetransverse connector 30′ may be bent with benders 52, 54 so thatsurfaces 50 of the elongated member openings 40 contact large areas ofthe elongated members 28. A torque limiting wrench 94 may be placed onthe transverse connector 30, and a shaft 92 of a drive tool 86 may beinserted through the hollow shaft 96 of the torque limiting wrench. Ahead 88 of a drive tool 86 may be inserted into a tool opening 74 of afirst cam system 42 of the transverse connector 30′. The drive tool 86may be rotated to rotate the cam system 42. Rotating the cam system 42may force an engager 68 into an elongated member opening 40 so that theengager presses an elongated member 28 against the surface 50 of theelongated member opening. The engager 68 may be a cam surface 70 of thecam system 42. The drive tool 86 may be removed from the tool opening 74of the first cam system 42. The drive tool 86 and the torque limitingwrench 94 may be repositioned so that the drive tool head 88 is insertedinto the tool opening 74 of the second cam system 42. The drive tool 86may be rotated to force an engager 68 against the second elongatedmember 28 so that the engager presses the second elongated memberagainst the second elongated member opening surface 50. Other transverseconnectors 30 may be attached to the elongated members 28 at otherlocations along the lengths of the elongated members.

FIG. 17 shows an exploded view of an embodiment of an adjustabletransverse connector 30″. The adjustable transverse connector 30″ mayinclude first section 46, second section 48, optional lining 104,fastener 106, elongated member openings 60 and cam systems 42. Theoptional lining 104 may be, but is not limited to, a bushing or asleeve. The fastener 106 may fix the position of the first section 46relative to the second section 48. The cam systems 42 may securelyfasten an elongated member 28 to a section 46 or 48 of the transverseconnector 30″. In alternate embodiments, an elongated member 28 may befastened to a transverse connector 30″ by connecting mechanisms otherthan cam systems 42. The other types of connecting mechanisms mayinclude, but are not limited to, setscrews, and connector and nutarrangements. Combinations of different types of connecting mechanismsmay also be used to couple a transverse connector 30″ to an elongatedmember 28.

A first section 46 of an adjustable transverse connector 30″ may includeshaft 108.

The shaft 108 may include flat surface 110. The shaft 108 may beinserted through a lining is 104 positioned within holder 112 of asecond section 48. The lining 104 may include circular bore 114. Thebore 114 may have a diameter that is slightly larger than diameter D(shown in FIG. 22) of the shaft 108. End 116 of the shaft 108 mayinclude countersunk opening 118 (as shown in FIG. 20) that allows theend to be peened after insertion through the holder 112 and lining 104.Peening the end 116 may inhibit removal of the lining 104 from theholder 112, and the first section 46 from the second section 48. Aseparation distance between centers of elongated member openings 40 ofthe transverse connector 30″ may be adjusted by moving elongated memberopening of the first section 46 towards or away from an elongated memberopening of the second section 48.

Several different transverse connectors 30″ may be formed with varyingadjustment ranges. An adjustment range of a transverse connector 30″ isthe range through which a separation distance between centers ofelongated member openings 40 may be adjusted. For example embodiments oftransverse connectors 30″ may be formed that have the followingoverlapping adjustment ranges.

Transverse connector size Adjustment range (mm) 1 37-44 2 43-51 3 50-654 61-80Other transverse connectors 30″ may be made that have differentadjustment ranges.

A holder 112 of a second section 48 of an adjustable transverseconnector 30″ may include first opening 120 and second opening 122. Thefirst opening 120 allows a lining 104 to be inserted into the holder 112so that a bore 114 of the lining aligns with the second opening 122. Inan embodiment, the first opening 120 may be a blind hole that does notextend completely through the holder 112. The second opening 122 allowsa first section shaft 108 to be placed through the holder 112 and thelining 104. Placing a shaft 108 of the first section 46 through theholder 112 and the lining 104 inhibits removal of the lining from theholder.

A fastener 106 may be used to apply force to a lining 104 to inhibitmovement of a first section 46 of an adjustable transverse connector 30″relative to a second section 48 of the transverse connector. In anembodiment, the fastener 106 is a setscrew that mates to threading 124in an upper section of the holder 112. Tightening the setscrew 106forces an end of the setscrew against a lining 104 to force a firstsection shaft 108 against the holder 112. The resulting forces betweenthe setscrew 106, the lining 104, the shaft 108 and the holder 112inhibit motion of the first section 46 relative to the second section48. Other types of fasteners 106 may be used. For example, in anembodiment the fastener 106 may be a cam mechanism that forces thelining 104 against the shaft 108 when the cam is engaged. In analternate embodiment, the fastener 106 may be a nut that threads to ashaft extending from the lining 104. A counter torque may be applied tothe transverse connector 30″ by a torque limiting wrench 94 to inhibitmovement of the transverse connector, stabilization system 32, orpatient when the fastener 106 is tightened.

The fastener 106 may include tool opening 74. Drive head 88 of drivetool 86 may be inserted into the tool opening 74. The drive tool 86 maybe rotated to rotate the fastener 106. Rotating the fastener 106 in aclockwise direction may press end 126 of the fastener against a top ofthe lining 104. The end 126 of the fastener 106 may have a large surfacearea to provide a large contact area with the lining 104. The contact ofthe fastener 106 against the lining 104 may press a shaft 108 against aholder 112 so that the axial, angular, and rotational motion of a firstsection 46 of a transverse connector 30″ relative to a second section 48of the transverse connector is inhibited. The drive tool 86 may be, butis not limited to, a diamond drive, a hex wrench, a star drive, ascrewdriver, or a socket wrench. Preferably, the drive tool 86 forfastener 106 is the same instrument that may be used to rotate fasteningsystems 42 that couple the transverse connector 30 to elongated members28. In alternate embodiments, tool openings 74 for cam systems 42 mayhave a different style than a tool opening for a fastener 106. Forexample, the tool openings 74 for the cam systems 42 may accept adiamond drive, while the tool opening 74 for the fastener 106 may beadapted to accept a drive head of a hex wrench.

FIG. 14 shows an embodiment of a drive tool 86 that may be used totighten a fastener 106 of a transverse connector 30″. The handle 90 ofthe drive tool 86 may include an opening 128. The opening 128 may beconfigured to accept drive 130 of torque wrench 132. FIG. 18 shows anembodiment of a torque wrench 132. The torque wrench 132 may be used toinform a user when sufficient torque has been applied to the fastener106. A sufficient amount of torque is enough torque to inhibit movementof a first section 46 of the transverse connector 30″ relative to thesecond section 48 of the transverse connector.

In alternate transverse connector embodiments, an optional lining 104may not be used. A fastener 106 may directly contact a shaft 108 of afirst section 46 of a transverse connector 30″ that is positionedthrough a holder 112 of a second section 48 of the transverse connector.The contact between the fastener 106, the shaft 108, and the holder 112may inhibit movement of the first section 46 relative to the secondsection 48.

A second opening 122 in a holder 112 may allow a first section 46 to beangulated relative to a second section 48. FIG. 19 shows a top view ofan embodiment of a transverse connector 30″ where the first section 46is angulated relative to the second section 48. Elongated members 28 ofan orthopedic stabilization system 32 may be horizontally skewedrelative to each other. The ability to angulate the first section 46relative to the second section 48 allows the transverse connector 30″ tobe coupled to elongated members 28 that are horizontally skewed. Inembodiments of stabilization systems 32, the elongated members may behorizontally parallel. To accommodate horizontally parallel elongatedmembers 28, the first section 46 may be adjusted relative to the secondsection 48 so that there is no angulation between the first section andthe second section.

To allow a first section 46 of a transverse connector 30″ to beangulated relative to a second section 48 of the transverse connector,width W (as shown in FIG. 22) of a second opening 122 in a holder 112 ofthe second section may be larger than a diameter D of a shaft 108passing through the holder. The large width W of the second opening 122allows the shaft 108 to slide laterally within the second opening 122until the fastener 106 is used to set the position of the shaft.

In an embodiment of a transverse connector 30″, an angulation range of afirst section 46 relative to a second section 48 may be from about 0° toabout 18°. The amount of angulation may be less or greater than 18° inother embodiments. For example, in an embodiment, the angulation rangeof the first section 46 relative to the second section 48 is from 0° to10°; and in another embodiment, the angulation range is from 0° to 30°.Larger or smaller ranges may also be used. A position of a secondopening 122 may be altered to change the limits of the angulation. Forexample, in an embodiment, the second opening 122 is positioned so thatthe angulation range is from 10° to 30°. Other embodiments may allow fordifferent amounts of angulation or for different angulation ranges. Ifthe transverse connector 30″ cannot be angulated in a desired directionwhen a first section 46 is placed on a first elongated member 28, thefirst section may be removed from the elongated member and placed on asecond elongated member to allow the transverse connector to beangulated in the desired direction.

A second opening 122 in a holder 112 may allow a first section 46 of atransverse connector 30″ to be rotated relative to a second section 48of the transverse connector. Elongated members 28 of an orthopedicstabilization system 32 may be vertically parallel, or the elongatedmembers may be vertically skewed relative to each other. If theelongated members 28 are vertically skewed relative to each other, theamount of skew is typically less than about 5°, but the skew may be aslarge as 20° or more. The ability to rotate the first section 46 of thetransverse connector 30″ allows the transverse connector to be coupledto vertically skewed elongated members 28.

To allow a first section 46 of a transverse connector 30″ to be rotatedrelative to a second section 48 of the transverse connector, a shaft 108of the first section is allowed to rotate within a lining 104. In anembodiment, height H of a second opening 122 in the second section 48 isslightly larger than a diameter D of the shaft 10. The height H of thesecond opening 122 allows the shaft 108 to be rotated a full 360°relative to the second section 48. In an alternate embodiment, which isshown in FIG. 22, the height H of the second opening 122 is smaller thanthe diameter D of the shaft 108 of the first section 46. A flat surface110 of the shaft 108 may limit the range of rotation of the firstsection 46 relative to the second section 48 to a useful range. If auser tries to rotate the first section 46 beyond a limited range, anedge of the flat surface 110 will contact the holder 112 and inhibitrotation of the first section 46 relative to the second section 48. Theflat surface 110 of the shaft 108 and the second opening 122 may allowthe first section 46 to rotate relative to the second section 48 aboutplus or minus 45° (for less than a 90° range of motion), preferably lessthan plus or minus 20° (for less than a 40° range of motion), and mostpreferably less than about plus or minus 10° (for less than a 20° rangeof motion). FIG. 21 shows an embodiment of a transverse connector 30″with a first section 46 that is rotated relative to a second section 48.

Limiting the range of rotational motion of the first section 46 relativeto the second section 48 may inhibit the rotation of the first sectioninto unusable positions. Unusable positions of the first section 46relative to the second section 48 are positions that do not allow foreasy instrument access to tool openings 74 of the transverse connector30″. For example, an embodiment of a transverse connector 30″ may allowthe first section 46 to rotate 360° relative to the second section 48.When the first section 46 is rotated 180° relative to the second section48, the elongated member opening 40 of one of the sections will beoriented upwards, while the elongated member opening of the othersection will be oriented downwards. The tool opening 74 of a cam system42 that fastens the section with the upwards facing elongated memberopening 40 to an elongated member 28 will not be easily accessible, andtherefore, the transverse connector 30 is in an unusable position.Limiting the range of rotational motion of the first section 46 relativeto the second section 48 may allow for easy instrument access to allparts of the transverse connector 30 that need to be tightened withoutexcessive manipulation of the transverse connector.

Elongated member openings 40 of a transverse connector 30 may be placedover elongated members 28 of an orthopedic stabilization system 32. Camsystems 42 may be used to fasten the transverse connector 30 to theelongated members 28. A cam system 42 may be positioned within a camsystem opening 60 in each section 46, 48 of the transverse connector 30.FIG. 20 shows a cross sectional view of an embodiment of a transverseconnector 30″. The sections 46, 48 of the transverse connector 30″ mayinclude cam system openings 60 for cam systems 42 (only one cam systemis shown in FIG. 20). The cam systems 42 and cam system openings 60 foran adjustable transverse connector 30″ may be the same as the camsystems and cam system openings for a fixed length transverse connector30′. FIG. 13 shows an embodiment of a cam system 42.

FIG. 23 shows an embodiment of a head 56 of a bender 52. The head 56 mayinclude two pockets 134 and 136. The first pocket 134 may be used tobend a fixed length transverse connector 30′. The second pocket 136 maybe used to bend an adjustable transverse connector 30″. FIG. 24 shows anadjustable transverse connector 30″ positioned within benders 52, 54.The benders 52, 54 may be used to “tent” the transverse connector 30″ sothat a middle portion of the transverse connector is the highest portionof the transverse connector when the transverse connector is installedin a patient.

To form a transverse connector 30″, a first section 46, a second section48, and a lining 104 are machined. Cam systems 42 are also machined. Theelongated member opening surfaces 50 and/or the contact surfaces of theengagers 68 may be textured so that the coefficient of friction betweenthe surfaces and elongated members 28 placed against the surfaces willbe high. Cam systems 42 are inserted into cam system openings 60 of thefirst section 46 and the second section 48. The cam systems 42 areinserted into the cam system openings 60 until the surfaces 82 of thecam systems pass the shoulders 62 of the openings. A lining 104 isplaced within a holder 112 of the second section 48. A shaft 108 of thefirst section 46 is inserted through the holder 112 and lining 104. End116 of the shaft 108 is peened or flared to inhibit removal of the firstsection 46 from the second section 48. A fastener 106 is coupled to theholder 112.

FIG. 7 shows an alternate embodiment of an adjustable transverseconnector 30″. The transverse connector 30″ may include first section46, second section 48, and fastener 106. FIG. 25 shows a cross sectionalview of a portion of the transverse connector 30″. The first section 46may include shaft 138. The shaft 138 may include flared end 140. Thesecond section 48 may include tapered collet 142 and hollow shaft 144.The fastener 106 may be a collar that is compression locked to thecollet 142. The collet 142 may include holding members 146, ledge 148,longitudinal slots 150 and shoulder 152. The collar 106 may include atapered bore 154 and tabs 156. The taper of the bore 154 maysubstantially correspond to the taper of the tapered collet 142. Amaximum diameter of the collet 142 may be greater than a maximumdiameter of the bore 154 of the collar 106. The tabs 156 may be placedwithin the longitudinal slots 150 in the collet 142 to couple the collar106 to the second section 48. The tabs 156 and the diameter of the bore154 relative to the diameter of the collet 142 may limit the axial rangeof motion of the collar 106 relative to the second section 48. The shaft138 of the first section 46 may be inserted into the hollow shaft 144 ofthe second section 48. The flared end 140 of the shaft 138 may contactthe ledge 148 of the collet 142 to inhibit the first section 46 frombeing separated from the second section 48.

A length of an adjustable transverse connector 30″ shown in FIG. 7 maybe adjusted by sliding a first section 46 axially relative to a secondsection 48. Also, the first section 46 may be rotated relative to thesecond section 48. The ability to rotate the first section 46 relativeto the second section 48 allows the transverse connector 30″ to be usedwith elongated members 28 that are skewed relative to each other suchthat the elongated members are not vertically parallel. When a desiredlength and rotation of the transverse connector 30″ is established, theposition of the first and second sections 46, 48 may be fixed to inhibitmovement of the first section relative to the second section.

A portion of the shaft 138 may include a flat surface. An insertpositioned and fixed within the hollow shaft 144 may limit the range ofrotational motion of the first section 46 within the second section 48.An edge of the flat surface of the shaft 138 may contact an edge of theinsert to limit the rotational range of the first section 46. Without aninsert, the shaft may be able to rotate 360° within the hollow shaft. Aninsert within the hollow shaft 144 may allow the first section 46 torotate relative to the second section 48 about plus or minus 45°,preferably less than plus or minus 20°, and most preferably less thanabout plus or minus 10°.

FIG. 26 shows an embodiment of a locking instrument 158 that may be usedto fix a position of a first section 46 of a transverse connector 30″relative to a second section 48. The locking instrument 158 may includefirst jaw 160, second jaw 162, first handle 164, and second handle 166.The first jaw 160 may be abutted against a shoulder 152 of a collet 142.The second jaw 162 may be abutted against front end 168 of the collar106. Squeezing the handles 164, 166 together forces the collar 106 ontothe collet 142 and compress the holding members 146 of the colletagainst the shaft 138 of the first section 46. Enough force may beapplied to the collar 106 to frictionally lock the collar to the collet142.

An outer surface of the shaft 138 and/or an inner surface of the holdingmembers 146 may be roughened to increase the coefficient of frictionbetween the first section 46 and the second section 48. Also, the innersurface of the collar 106 and/or the outer surface of the collet 142 maybe roughened to increase the coefficient of friction between the collarand the collet.

To establish a bone stabilization system 32 using an adjustabletransverse connector 30″, a pair of contoured elongated members 28, or asingle elongated member that is bent and contoured to fit on adjacentsides of a bone 34 or bones that are to be stabilized, may be coupled tothe bone or bones being stabilized. The elongated members 28 may becoupled to the bone 34 or bones by fixation elements 36, as shown inFIG. 3. If necessary or desired, the transverse connector 30″ may bebent using a pair of benders 52, 54 so that a middle portion of thetransverse connector will be the highest part of the transverseconnector when the transverse connector is installed in a patient. Afirst section 46 and a second section 48 of the transverse connector 30″may be placed over the elongated members 28 so that the elongatedmembers are positioned within elongated member openings 40 of thetransverse connector 30 at a desired location. The length, angulation,and rotation of the transverse connector 30″ may be adjusted so that theelongated members 28 are positioned within the elongated member openings40 with a large contact area between the elongated member openingsurfaces 50 and the elongated members. A torque limiting wrench 94 maybe placed on the transverse connector 30, and a shaft 92 of a drive tool86 may be inserted through the hollow shaft 96 of the torque limitingwrench. A head 88 of a drive tool 86 may be inserted into a tool opening74 of a first cam system 42 of the transverse connector 30. The drivetool 86 may be rotated to rotate the cam system 42 while applyingcounter torque with the torque limiting wrench 94. Rotating the camsystem 42 may extend a cam 70 into an elongated member opening 40 sothat the cam presses the elongated member 28 against the surface 50 ofthe elongated member opening. The drive tool 86 may be removed from thetool opening 74 of the first cam system 42.

The drive tool 86 and torque limiting wrench 94 may be repositioned sothat the torque limiting wrench engages the transverse connector 30 andthe head 88 of the drive tool 86 is inserted into the tool opening 74 ofthe second cam system 42. The drive tool 86 may be rotated, whileapplying counter torque with the torque limiting wrench 94, to force acam 70 against the second elongated member 28 so that the cam pressesthe second elongated member against the second elongated member openingsurface 50.

The torque limiting wrench 94 and the drive tool 86 may be repositionedso that the torque limiting wrench engages the transverse connector 30and the head 88 of the drive tool is inserted into the tool opening 74of the fastener 106. The fastener 106 may be tightened. A torque wrench132 may be inserted into the opening 128 of the handle 90. The torquewrench 132 may be used to tighten the fastener 106 while counter torqueis applied with the torque limiting wrench 94. Other transverseconnectors 30 may be attached to the elongated members 28 at otherlocations along the lengths of the elongated members.

Further modifications and alternative embodiments of various aspects ofthe invention will be apparent to those skilled in the art in view ofthis description. Accordingly, this description is to be construed asillustrative only and is for the purpose of teaching those skilled inthe art the general manner of carrying out the invention. It is to beunderstood that the forms of the invention shown and described hereinare to be taken as the presently preferred embodiments. Elements andmaterials may be substituted for those illustrated and described herein,parts and processes may be reversed, and certain features of theinvention may be utilized independently, all as would be apparent to oneskilled in the art after having the benefit of this description of theinvention. Changes may be made in the elements described herein withoutdeparting from the spirit and scope of the invention as described in thefollowing claims.

1. An adjustable transverse connector, comprising: a first sectionhaving a holder and a first fastening system, wherein the firstfastening system is configured to couple the first section to a firstelongated member of an orthopedic stabilization system; a second sectionhaving a connecting member and a second fastening system, wherein thesecond fastening system is configured to couple the second section to asecond elongated member of the orthopedic stabilization system andwherein a portion of the connecting member of the second section ispositioned in the holder of the first section; and a fastener configuredto fix a position of the connecting member of the second sectionrelative to the holder of the first section.
 2. The adjustabletransverse connector of claim 1, wherein a distance between the firstelongated member and the second elongated member of the orthopedicstabilization system is adjustable through positioning the connectingmember of the second section relative to the holder of the first sectionbefore the fastener is fastened to fix the position of the connectingmember of the second section relative to the holder of the firstsection.
 3. The adjustable transverse connector of claim 1, furthercomprising a bushing between the connecting member of the second sectionand the holder of the first section.
 4. The adjustable transverseconnector of claim 3, where the fastener comprises a cam mechanism thatforces the busing against the connecting member when the cam is engaged.5. The adjustable transverse connector of claim 1, further comprising alining between the connecting member of the second section and theholder of the first section.
 6. The adjustable transverse connector ofclaim 5, where the fastener comprises a nut that threads to a shaftextending from the lining.
 7. The adjustable transverse connector ofclaim 1, where the holder of the first section has a threaded openingand wherein the fastener is a setscrew that mates with the threadedopening of the holder.
 8. The adjustable transverse connector of claim1, wherein the holder of the first section comprises a first openingconfigured to accept the fastener and a second opening configured toaccept the connecting member of the second section.
 9. The adjustabletransverse connector of claim 1, wherein the first opening of the holderis a blind hole that does not extend completely through the holder. 10.The adjustable transverse connector of claim 1, wherein the connectingmember of the second section comprises a flat surface.
 11. Theadjustable transverse connector of claim 1, wherein the holder of thefirst section has an opening through which the connecting member iscoupled to the first section.
 12. The adjustable transverse connector ofclaim 11, wherein the connecting member of the second section comprisesa flat surface and wherein the opening of the holder has a correspondingflat surface.
 13. The adjustable transverse connector of claim 1,wherein the connecting member of the second section comprises acountersunk opening.
 14. An orthopedic stabilization system, comprising:a first elongated member; a second elongated member; and an adjustabletransverse connector, comprising: a first section having a holder and afirst fastening system, wherein the first fastening system is configuredto couple the first section of the adjustable transverse connector tothe first elongated member; a second section having a connecting memberand a second fastening system, wherein the second fastening system isconfigured to couple the second section of the adjustable transverseconnector to the second elongated member and wherein a portion of theconnecting member of the second section is positioned in the holder ofthe first section, wherein a distance between the first elongated memberand the second elongated member is adjustable through positioning theconnecting member of the second section relative to the holder of thefirst section; and a fastener configured to fix a position of theconnecting member of the second section relative to the holder of thefirst section.
 15. The orthopedic stabilization system of claim 14,wherein the adjustable transverse connector further comprises a lining,a bushing, or a sleeve between the connecting member of the secondsection and the holder of the first section.
 16. The orthopedicstabilization system of claim 14, wherein the fastener comprises a cammechanism that forces the busing against the connecting member when thecam mechanism is engaged, a nut that threads to a shaft extending fromthe lining, or a setscrew that mates with a threaded opening of theholder.
 17. The orthopedic stabilization system of claim 14, wherein theholder of the first section accept the connecting member of the secondsection, wherein the connecting member of the second section comprises aflat surface, wherein the second opening of the holder has acorresponding flat surface, and wherein fixing the position of theconnecting member of the second section relative to the holder of thefirst section inhibits axial, angular, and rotational motion of thefirst section relative to the second section.
 18. The orthopedicstabilization system of claim 14, wherein the holder of the firstsection comprises a first opening configured to accept the fastener anda second opening configured to accept the connecting member of thesecond section, wherein the second opening has a width that is slightlylarger than a diameter of the connecting member, allowing the connectingmember to slide laterally within the second opening of the holder beforethe position of the connecting member of the second section is fixedrelative to the holder of the first section.
 19. An adjustabletransverse connector, comprising: a first section having a body, aholder at a first end of the body, a first elongated member opening at asecond end of the body, and a first fastening system positioned betweenthe first end and the second end of the body and extending into thefirst elongated member opening, wherein the holder has a verticalopening and a lateral opening; at least one second section having ashaft, a second elongated member opening, and a second fastening systempositioned between the shaft and the second elongate member opening andextending into the second elongate member opening, wherein the lateralopening of the holder of the first section has a width that accommodatesor is slightly larger than a diameter of the shaft; and a fastener thatmates with the vertical opening of the holder to fix a position of theshaft of the second section relative to the holder of the first section.20. The adjustable transverse connector of claim 19, further comprises alining, a bushing, or a sleeve that fits inside the vertical opening ofthe holder of the first section and that contacts a portion of the shaftwhen the shaft engages the first section through the lateral opening,wherein the fastener comprises a cam mechanism that forces the busingagainst the shaft when the cam mechanism is engaged, a nut that threadsto a shaft extending from the lining, or a setscrew that mates with thevertical opening of the holder.